Electrosurgical blade with minimally exposed edge, alternative to coated blade

ABSTRACT

A cutting element for an electrosurgical device. The cutting element includes an elongate non-conductive body having a first face opposite a second face, the first face and the second face defining an edge there between. A conductive element is disposed only along the edge, the conductive element being configured to cut tissue with monopolar radiofrequency energy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/841,790, filed Dec. 14, 2017, entitled ELECTROSURGICAL BLADE WITHMINIMALLY EXPOSED EDGE, ALTERNATIVE TO COATED BLADE, which is related toand claims priority to U.S. Provisional Patent Application Ser. No.62/434,753, filed Dec. 15, 2016, entitled ELECTROSURGICAL BLADE WITHMINIMALLY EXPOSED EDGE, ALTERNATIVE TO COATED BLADE, the entirety ofwhich are incorporated herein by reference.

TECHNICAL FIELD

This present invention relates to electrosurgical devices, and inparticular, monopolar radiofrequency electrosurgical devices.

BACKGROUND

Monopolar electrosurgical devices are surgical devices that areconfigured to dissect tissue with radiofrequency energy as opposed todissection of tissue with a traditional scalpel. One of the mainbenefits of such devices are precision dissection on par with that ofscalpel while providing the bleeding control capability of traditionalelectrosurgery with minimal thermal injury to collateral tissue. Thisresults in a highly efficient cut that requires less power to operateand improves patient outcomes by reducing collateral tissue damage.

Currently, some monopolar electrosurgical devices are manufactured byincluding a conductive substrate, such as an electrode, that is coatedwith a glass-based insulator material. In some devices, the resultingcutting tip includes minimally exposed conductive edge that is in therange of 1 to 100 microns in width. Therefore, approximately greaterthan 99% of the cutting tip is insulated and less than 1% is exposed.This minimally exposed edge enables the focused energy to be deliveredonly at the exposed edge, while the remainder of the tip is insulatedand kept at a relatively low temperature. The end result is precisioncutting with minimal collateral damage. However, this method ofmanufacture requires an expensive glass-coating process, potential formanufacturing efficiency, and reduction in reliance on highly custommaterials.

SUMMARY

Some embodiments advantageously provide for a cutting element for anelectrosurgical device. The cutting element includes an elongatenon-conductive body having a first face opposite a second face, thefirst face and the second face defining an edge there between. Aconductive element is disposed only along the edge, the conductiveelement being configured to cut tissue with monopolar radiofrequencyenergy.

In another aspect of this embodiment, the edge is a chamfered edge.

In another aspect of this embodiment, the first face and the second faceare substantially flat.

In another aspect of this embodiment, the conductive element is composedof one from the group consisting of silver alloy and gold alloy.

In another aspect of this embodiment, the elongate non-conductive bodyis composed of Zirconium toughened Alumina.

In another aspect of this embodiment, the elongate non-conductive bodyincludes a proximal end and a distal end, and wherein the distal end iscurved.

In another aspect of this embodiment, the conductive element is etchedonto the elongate non-conductive body.

In another aspect of this embodiment, the elongate non-conductive bodydefines a perimeter and wherein the conductive element is disposedaround the perimeter.

In another aspect of this embodiment, the elongate non-conductive bodyincludes a soldered conductor on the first face, the conductor beingconfigured to electrically couple the conductive element to a shaft ofthe electrosurgical device.

In another aspect of this embodiment, the cutting element is configuredto be coupled to an elongate shaft, and wherein the elongate shaft iscoupled to a handle of the electrosurgical device.

In another embodiment, a cutting element for an electrosurgical deviceincludes an elongate non-conductive body having a first face opposite asecond face and defining a major longitudinal axis, the first face andthe second face defining a double chamfered edge there between. Aconductive element is disposed only along the double chamfered edge, theconductive element being substantially perpendicular to the majorelongate axis, the conductive element being configured to cut tissuewith monopolar radiofrequency energy.

In another aspect of this embodiment, the conductive element is one fromthe group consisting of gold alloy ink and silver alloy ink printed onthe double chamfered edge.

In another aspect of this embodiment, the first face and the second faceare substantially flat.

In another aspect of this embodiment, the elongate non-conductive bodyis composed of Zirconium toughened Alumina.

In another aspect of this embodiment, the elongate non-conductive bodyincludes a proximal end and a distal end, and wherein the distal end iscurved.

In another aspect of this embodiment, the elongate non-conductive bodydefines a perimeter and wherein the conductive element is disposedaround substantially the entirety of the perimeter.

In another aspect of this embodiment, the elongate non-conductive bodyincludes a soldered conductor on the first face, the conductor beingconfigured to electrically couple the conductive element to a shaft ofthe electrosurgical device.

In another aspect of this embodiment, the cutting element is configuredto be coupled to an elongate shaft, and wherein the elongate shaft iscoupled to a handle of the electrosurgical device.

In another aspect of this embodiment, the conductive element is disposedalong a midpoint of a width of the conductive element.

In another embodiment, an electrosurgical device includes a handle. Anelongate shaft extends from the handle, the elongate shaft defines aproximal end coupled to the handle and a distal end. A cutting elementis coupled to the distal end of the shaft, the cutting element includesa flat and elongate non-conductive body having a first face opposite asecond face and defines a major longitudinal axis, the first face andthe second face define a double chamfered edge there between, thenon-conductive body defines a proximal end coupled to the elongate shaftand an arcuate distal end. A conductive element composed of a silveralloy is printed only along the double chamfered edge, the conductiveelement being substantially perpendicular to the major elongate axis,the conductive element being configured to cut tissue with monopolarradiofrequency energy.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of embodiments described herein, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a system view of an electrosurgical unit and electrosurgicaldevice constructed in accordance with the principles of the presentapplication;

FIG. 2 is a perspective view of the cutting element of theelectrosurgical device shown in FIG. 1 ;

FIG. 3 is a side view of the cutting element shown in FIG. 2 ;

FIG. 4 is a top view of the cutting element shown in FIG. 3 ; and

FIG. 5 is a bottom view of the cutting element shown in FIG. 4 .

DETAILED DESCRIPTION

As used herein, relational terms, such as “first” and “second,” “top”and “bottom,” and the like, may be used solely to distinguish one entityor element from another entity or element without necessarily requiringor implying any physical or logical relationship or order between suchentities or elements.

As used herein, relational terms, such as “first” and “second,” “top”and “bottom,” and the like, may be used solely to distinguish one entityor element from another entity or element without necessarily requiringor implying any physical or logical relationship or order between suchentities or elements.

Referring now to the drawings in which like reference designators referto like elements, there is shown in FIG. 1 and exemplary electrosurgicalunit (“ESU”) constructed in accordance with the principles of thepresent application and designated generally as “10.” The ESU 10 mayinclude a radiofrequency generator 12 configured to house andelectrically couple the components and circuits of the ESU 10 and atouch actuated display 14 configured to receive energy requests from oneor more electrosurgical hand pieces that electrically couple to theradiofrequency generator 12, display treatment progress andmeasurements, for example, impedance, and initiate and/or terminate thesupply of radiofrequency energy and fluid with one or moreelectrosurgical hand pieces that may be electrically coupled to the ESU10. In an exemplary configuration, the ESU 10 includes a firstreceptacle 16, which may be a 3-pin connector configured to receive andelectrically couple with a bipolar electrosurgical hand piece (notshown) configured to deliver bipolar radiofrequency energy to tissue.The ESU 10 may further include a second receptacle 18, for example, a7-pin receptacle, configured to receive and electrically couple with anelectrosurgical hand piece 20 configured to deliver at least one ofmonopolar radiofrequency energy or a combination of bipolarradiofrequency energy and monopolar radiofrequency energy. Additionaldetails about an exemplary ESU 10 of the present application may foundin U.S. patent application Ser. No. 14/927,999, filed Oct. 30, 2015,entitled RF OUTPUT STAGE SWITCHING MECHANISM, the entirety of which isincorporated herein by reference. In other configurations, the ESU 10may include a single receptacle configured to deliver one or both ofmonopolar and bipolar radiofrequency energy to which the bipolarelectrosurgical hand piece or the electrosurgical hand piece 20 maycouple with.

Continuing to refer to FIG. 1 , the electrosurgical hand piece 20 themay include a handle 22 which couples to the second receptacle 18 andincludes a first actuator 24 configured to initiate operation of thehand piece 20 in CUT mode, a second actuator 26 configured to initiateoperation of the hand piece 20 in COAG mode, and a third actuator 28configured to initiate operation of the hand piece 20 in TRANS mode.Although three actuators are shown which initiate various functions ofthe hand piece 20, it is contemplated that only the first actuator 24may be included, or the first actuator 24 and the second actuator 26 mayonly be included. As described herein CUT mode operates the hand piece20 to dissect and/or resect tissue; COAG mode operates the hand piece 20to coagulate tissue for hemostasis; and TRANS mode operates the handpiece 20 to coagulate tissue while releasing a fluid.

Extending distally from the handle 22 may be an elongate shaft 30defining a proximal end 32, a distal end 34, and a lumen 36 therebetween. The proximal end 32 of the shaft 30 may be coupled to thedistal end of the handle 22. In an exemplary configuration, one or moreconductors (not shown) may extend through the handle 22 and connect tothe shaft 30 or extend through the lumen 36 toward the distal end 34 ofthe shaft 30 to electrically connect the ESU 10 with the hand piece 20when the hand piece 20 is coupled to the second receptacle 18.Alternatively, the shaft 30 may be composed of an electricallyconductive material, such as stainless steel, and may function as aconductor to transfer radiofrequency energy from the ESU 10 to thedistal end 34 of the shaft 30. In one configuration the shaft 30 may bemalleable such that it may be manipulated from a first configurationinto a second configuration and optionally may be extendable andretractable by pulling or pushing on a finger grip 31. In an exemplaryconfiguration, the shaft 30 may be covered with an insulating materialsuch as heat shrink such that the interior of the shaft 30 may beconductive but the exterior of the shaft 30 may be insulated. In oneconfiguration, a fluid conduit 38 may be disposed within the lumen 36shaft 30 spanning from the proximal end 32 to the distal end 34. Thefluid conduit 38 may be configured to transport fluid, such as salinefrom the ESU 10 having an integrated fluid source 40 or a separate fluidsource 40 to the distal end 34 of the shaft 30. In an exemplaryconfiguration, the fluid conduit 38 may be insulated from the shaft 30such that fluid transported within the fluid conduit is not energizedbefore it exits the distal end 34 of the shaft 30. In anotherconfiguration, the fluid conduit 38 is in electrical communication withthe shaft 30 such that fluid exiting the distal end 34 of the shaft 30is energized.

Now referring to FIGS. 1 and 2 , extending from the distal end 34 of theshaft 30 may include a cutting element 42 configured to cut, coagulate,and/or coagulate tissue with a fluid with monopolar radiofrequencyenergy. In one configuration, the cutting element 42 may be composed ofa non-conductive substrate such as ceramic, for example, aluminum oxideor Zirconium toughened Alumina. The cutting element 42 may be elongatein shape and may include a first face 44 opposite a second face 46(shown in FIG. 4 ). In one configuration, for example, the configurationshown in FIG. 2 , the first face 44 and the second face 46 may be flatand in another configuration the first face 44 and/or the second face 46may define a curved surface, whether a concavity or convexity. Thecutting element 42 may include a proximal end 48, which permanently orreleasably couples with the distal end 34 of the shaft 30, and a distalend 50. For example, the proximal end 48 may be molded or soldered tothe shaft 30, or alternatively, the proximal end 48 may snap-fit orinclude a bayoneted-type connection to releasably couple to the shaft30. The distal end 50 may be curved, arcuate, flat, beveled, sharp orany number of configurations depending on the application. In anexemplary configuration, the cutting element 42 may define a length(“1”) of 0.50″, with a range in other embodiments from 0.25″ to 2.0″; awidth (“w”) of 0.15″, with a range in other embodiments from 0.10″ to0.70″ and a thickness (“t”) of 0.03″, with a range in other embodimentsfrom 0.01″ to 0.07″.

Referring now to FIGS. 2-5 , the first face 44 and the second face 46may cooperate to define an edge 52 along the perimeter of the cuttingelement 42. In particular, the first face 44 and the second face 46 mayeach taper in thickness as they extend toward the perimeter of thecutting element such the first face 44 and the second face 46 define achamfered edge 52 around the perimeter of the cutting element 42. Inother words, the first face 44 and the second face 46 may define adouble chamfered edge as shown in FIG. 4 . Alternatively, only one ofthe first face 44 and second face 46 may define a chambered edge, whilethe other is flat. The edge 52 may include a conductive element 54deposited or otherwise printed on its surface. In particular, a tracematerial, such as silver alloy ink, gold ink, or other metallic or metalallow materials may be etched or otherwise deposited onto the surface ofthe of the cutting element 42 along only the edge 52. The conductiveelement 54 may completely or partially surround the cutting element 42.For example, the conductive element 54 may be disposed on one side ofthe cutting element 42 such that the edge 52 is only conductive on asingle side of the cutting element; the conductive element 54 may bedisposed only at the distal end of the cutting element 42 on the curvedportion of the distal end 50; or the conductive element 54 may bedisposed on the edge 50 around the entire perimeter of the cuttingelement 42. In one configuration, the conductive element 54 defines aflat and co-planar surface with the edge 52 and about the midpointbetween the width of the face 44 and the second face 46. In an exemplaryconfiguration, the edge 52 thickness, after etching on the conductiveelement 54 may be define a thickness of 0.006″, with a range in otherembodiments from 0.003″ to 0.10″. The conductive element 54 may be inelectrical communication with the shaft 30, and therefore the ESU 10, byeither directly coupling to the distal end 34 of the shaft 30 or by aseparate conductor (not shown). For example, the cutting element 42 mayfurther include a soldering strip 56 configured to electrically couplethe cutting element 42 to the shaft 30. The soldering strip 56 mayfurther be electrically coupled to the conductive element 54 such thatradiofrequency energy may be directed from the ESU 10 to the cuttingelement 42. In an exemplary configuration, the soldering strip 56 isdisposed on the first face 44 and not on the second face 46. In otherconfigurations, the soldering strip surrounds the cutting element 42.The cutting element 42 may further include a port (not shown) proximatethe proximal end 48 configured to release fluid from the fluid conduit38 onto the cutting element 42. In such a configuration, the cuttingelement 42 may be configured to coagulate tissue while releasing aconductive fluid such as saline. In another configuration, one or moreconductors (not shown) may be disposed within the cutting element 42sandwiched between the first face 44 and the second face 46. The one ormore conductors may be configured to provide a current pathway to theconductive element 54 should a section of the conductive element 54break-off or otherwise erode during application of electrosurgicalenergy, which may create a short. For example, the one or moreconductors may define a mesh-like configuration and may be coupled tovarious locations along the perimeter of the conductive element 54 toprovide a back-up conductive pathway should a portion of the conductiveelement erode and disrupt the current pathway.

It will be appreciated by persons skilled in the art that the presentembodiments are not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope of thefollowing embodiments.

What is claimed is:
 1. A cutting element for an electrosurgical device,comprising: a conductive shaft; an elongate non-conductive body defininga major longitudinal axis having a first face opposite a second face,the first face and the second face joining to define an edge: aconductive element configured to cut tissue with monopolarradiofrequency energy; and the elongate non-conductive body includes asoldering strip disposed only on the first face and the edge, thesoldering strip spanning an entire width of a proximal portion of theelongate non-conductive body transverse to the major longitudinal axis,the soldering strip being configured to electrically couple theconductive element to the conductive shaft of the electrosurgicaldevice.
 2. The cutting element of claim 1, wherein the edge is achamfered edge.
 3. The cutting element of claim 1, wherein the firstface and the second face are flat.
 4. The cutting element of claim 1,wherein the conductive element is composed of one from the groupconsisting of silver allow and gold alloy.
 5. The cutting element ofclaim 1, wherein the elongate non-conductive body is composed ofzirconium toughened alumina (ZTA).
 6. The cutting element of claim 1,wherein a distal end of the elongate non-conductive body is curved. 7.The cutting element of claim 1, wherein the conductive element is etchedonto the elongate non-conductive body.
 8. The cutting element of claim7, wherein the elongate non-conductive body defines a perimeter andwherein the conductive element is disposed around the perimeter.
 9. Acutting element for an electrosurgical device, comprising: a conductiveshaft; an elongate non-conductive body having a first face opposite asecond face and defining a major longitudinal axis, the first face andthe second face joining to define a double chamfered edge: a conductiveelement configured to cut tissue with monopolar radiofrequency energy;and the elongate non-conductive body includes a soldering strip disposedonly on the first face and the double chamfered edge, the solderingstrip spanning an entire width of a proximal portion of the elongatenon-conductive body and transverse to the major longitudinal axis, thesoldering strip being configured to electrically couple the conductiveelement to the conductive shaft of the electrosurgical device.
 10. Thecutting element of claim 9, wherein the conductive element is one fromthe group consisting of gold alloy ink and silver alloy ink printed onthe double chamfered edge.
 11. The cutting element of claim 9, whereinthe first face and the second face are flat.
 12. The cutting element ofclaim 9, wherein the elongate non-conductive body is composed of ZTA.13. The cutting element of claim 9, wherein the conductive shaft iscomposed of stainless steel.
 14. An electrosurgical device, comprising:a handle; a conductive elongate shaft extending from the handle anddefining a major longitudinal axis, the conductive elongate shaftdefining a proximal end coupled to the handle and a distal end oppositethe proximal end; a cutting element coupled to the distal end of theconductive elongate shaft; a conductive element configured to cut tissuewith monopolar radiofrequency energy; and the elongate non-conductivebody includes a soldering strip disposed only on the first face and thedouble chamfered edge, the soldering strip spanning an entire width of aproximal portion of the elongate non-conductive body transverse to themajor longitudinal axis, the soldering strip being configured toelectrically couple the conductive element to the conductive elongateshaft of the electrosurgical device.
 15. The electrosurgical device ofclaim 1, wherein the edge is a double chamfered edge and the doublechamfered edge has a thickness of 0.006″.
 16. The electrosurgical deviceof claim 15, wherein the thickness of the conductive element and thedouble chamfered edge is between 0.003″ and 0.10″.